Including Carer Quality of Life in Health Technology Evaluation: Are We There Yet?

Carer quality of life impacts can be included in health technology evaluations, however little guidance is provided. NICE considered providing more guidance as part of their recent methods review. Ultimately, a set of ‘minimum evidence requirements’ were produced, but these were not included in the new manual as further research and stakeholder input is required. This blog provides a summary and critique of these requirements.

This blog post is the third in a series on the new National Institute for Health and Care Excellence (NICE) health technology evaluation manual. Each post provides a critical discussion on a particular topic, including the expected implications of the changes (or lack thereof) in the manual, what is still missing, and what further research is needed.

Health technologies benefit more than just the patient. In practice, new treatments can benefit a range of individuals within the patient’s network. This is particularly the case when a new treatment means that the patient requires less ‘informal care’. Informal care is unpaid care provided by people that have a relationship with the patient (e.g., spouses, parents, and children). For example, it is common for spouses to provide care to people with Parkinson’s and Alzheimer’s disease and for parents to provide care to children with cystic fibrosis and spinal muscular atrophy.

It has been shown that informal carers can face significant health impacts as a result of their caring responsibilities (Wu et al. 2020). Therefore, new treatments that reduce the need for informal care can improve the quality of life (QOL) of informal carers whilst also improving the QOL of patients.

What did NICE consider during the methods update, and what changes have been made?

The previous version of NICE’s health technology evaluation manual allowed the inclusion of health effects for informal carers in evaluations. However, there was no clear guidance on when and how it should be done. Therefore, NICE tasked its ‘Health-Related Quality of Life Task & Finish Group’ (HRQOL T&F group) with exploring whether there was a case for providing more guidance and, if so, to consider what might be required.

In the end, whilst the HRQOL T&F group did consider that more guidance would be warranted. They put together a set of ‘minimum evidence requirements’ but stated that these need to be informed by further input from a range of stakeholders because normative judgements are required.

The conclusion was recently summarised by Dawoud et al. (2022):

“The final manual, therefore, states that evidence should be provided to show that the condition is associated with a substantial impact on carer HRQoL, without setting minimum standards at this time.”

In other words, expect changes in future. For now, the best indicator of the ‘direction of travel’ is the minimum evidence requirements.

So, what is included in the minimum evidence requirements?

The minimum evidence requirements summarise the type of evidence that might be useful for illustrating that carer QOL effects should be considered, such as published carer burden studies. It was also suggested that carer QOL should be measured using EQ-5D for consistency with patient QOL data and to ensure comparability between appraisals.

Additionally, it was suggested that carer QOL effects should only be considered for one individual (the ‘primary carer’), and that no additional weight should be given based on the relationship between the carer and the patient (for example, if the carer is a parent caring for their child). Finally, it was also suggested that bereavement effects should not be included in models because the impact is ‘unpredictable’, and methods in that area are ‘not well developed’.

What is OHE’s view?

NICE has committed to further discussions on this topic, and future changes may or may not be in line with the proposed minimum evidence requirements. Nonetheless, the progress on this topic and the suggestions made by the HRQOL T&F group are somewhat disappointing for several reasons.

Firstly, the requirement for evidence to be provided to show that the carer QOL impact is ‘substantial’ to justify its inclusion in evaluations is unnecessary. If the impact is not substantial, it will have little impact. The inclusion of carer QOL impacts should improve the efficiency and equity of evaluations (Brouwer, 2018), and its inclusion should, therefore, arguably be encouraged rather than hindered by ill-defined requirements.

Additionally, the need for EQ-5D to be used to measure carer QOL impacts is somewhat restrictive, given that alternative measures that have been specifically designed to measure carer QOL have been developed and may be more responsive. Further research is required to test the appropriateness of these measures in different contexts. However, in the new manual, NICE has put forward a hierarchy for measuring patient QOL, and arguably something similar should be provided for measuring carer QOL.

Finally, the issues of how many carers to consider in evaluations and the consideration of bereavement effects are contentious. Many patients receive informal care from several people, and considering only one informal carer would constitute a significant underestimate of the overall impact. Furthermore, without consideration of bereavement effects, typical modelling approaches are likely to assume that informal carers’ QOL returns to the same level as the general population upon the death of the person they cared for, which is not realistic. However, we acknowledge that further research is required on these topics.

OHE is currently working on a project that will be looking into some of these issues, particularly in relation to the appropriate modelling approaches for carer QOL, and hope to contribute to NICE’s ongoing efforts in this area.

Citation

Brouwer, W. B. F. (2019). The Inclusion of Spillover Effects in Economic Evaluations: Not an Optional Extra. PharmacoEconomics, 37(4), 451–456.

Dawoud, D., Lamb, A., Moore, A., Bregman, C., Rupniewska, E., Paling, T., Wolfram, V., Lovett, R. E. S., & Dent, R. (2022). Capturing what matters: updating NICE methods guidance on measuring and valuing health. Quality of Life Research. https://doi.org/10.1007/s11136-022-03101-6

Wu, Y., Al-Janabi, H., Mallett, A., Quinlan, C., Scheffer, I. E., Howell, K. B., Christodoulou, J., Leventer, R. J., Lockhart, P. J., Stark, Z., Boughtwood, T., & Goranitis, I. (2020). Parental health spillover effects of paediatric rare genetic conditions. Quality of Life Research, 29(9), 2445–2454.

Related research

Mott, D. J., Leslie, I., Shah, K., Rowell, J., & Scheuer, N. (2021). Impact of Including Carer Information in Time Trade-Off Tasks: Results from a Pilot Study. PharmacoEconomics – Open, 5(4), 665–675.

Sampson, C. & Garau, M. (2019). How Should We Measure Quality of Life Impact in Rare Disease? Recent Learnings in Spinal Muscular Atrophy. OHE Briefing. https://www.ohe.org/publications/how-should-we-measure-quality-life-impact-rare-disease-recent-learnings-spinal-muscular

Related blogs

A series on the new National Institute for Health and Care Excellence (NICE) health technology evaluation manual

• New NICE Manual for Health Technology Evaluations: A Critical Discussion on the Most Relevant Changes (or Lack Thereof)
• To Hell with the 3L! NICE’s Missed Opportunity to Upgrade Health Outcome Measurement
• The NICE Health Technology Evaluation Manual: A Fresh Perspective Needed?
• NICE’s severity modifier: a step in the right direction, but still a long way to go